Performer G09843Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002098435), received between Jan 10, 2019 and Feb 24, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  IT WAS ORIGINALLY REPORTED THAT THE TIP OF THE DILATOR OF A PERFORMER INTRODUCER WAS "DISTORTED" WHEN IT CAME OUT OF THE PACKAGE. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT AND PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING AN UNSPECIFIED DILATOR FROM A DIFFERENT MANUFACTURER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 09FEB2026, A CRACK WAS NOTED ON THE TIP OF THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431059 ↗
• InjuryJan 23, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN INTERVENTION, A PERFORMER INTRODUCER "TORE IN TWO" UPON REMOVAL OF THE DEVICE. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED VIA AN OPEN SURGICAL APPROACH "TO THE SCARPA". A SCALPEL WAS USED DURING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223034 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 17740850 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  AS REPORTED, AT THE BEGINNING OF A MECHANICAL THROMBECTOMY PROCEDURE, A PERFORMER INTRODUCER LEAKED AND THE SILICONE DISC WAS REPORTEDLY MISSING. LEFT FEMORAL ACCESS WAS OBTAINED TO TARGET THE PULMONARY ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. ANOTHER MANUFACTURER'S 12 FRENCH THROMBECTOMY DEVICE WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. ALTHOUGH BLEEDING WAS REPORTED, THE PATIENT DID NOT REQUIRE ANY INTERVENTION/TREATMENT FOR BLOOD LOSS. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740808 ↗
• MalfunctionApr 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797290 ↗
• MalfunctionNov 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, WHILE INSERTING THE DILATOR THROUGH THE CHECK-FLO VALVE OF A PERFORMER INTRODUCER ON THE PREP TABLE, THE VALVE DISLODGED AND "PUSHED FURTHER INTO THE PLASTIC CASING." THE DEVICE WAS REPLACED WITH A NEW SHEATH TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752896 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL PROCEDURE, THE SILICONE DISC VALVE IN THE CHECK-FLO ASSEMBLY ON A PERFORMER INTRODUCER DISLODGED. THIS WAS NOTICED UPON OPENING THE PACKAGING OF THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310806 ↗
• MalfunctionJan 10, 2019Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233272 ↗
• MalfunctionJan 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PERFORMER INTRODUCER WAS FOUND WITH A LOOSE VALVE. PER THE INITIAL REPORTER, THE VALVE COULD NOT BE TIGHTLY SECURED. THIS MALFUNCTION WAS SAID TO HAVE BEEN OBSERVED PRIOR TO PATIENT CONTACT. NO ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8233231 ↗